Abstract

European legislation requires that manufacturers of medical devices compile a file containing data demonstrating the safety and performance of the specified device. The quality of the files on medical devices falling into the highest risk class (Class III) needs to be improved. This is the conclusion of an investigation performed by the Dutch National Institute for Public Health and the Environment (RIVM) by order of the Netherlands Health Care Inspectorate. The investigation was based on technical documentation submitted by manufacturers of medical devices. The medical devices themselves were not examined. In total, 25 dossiers on medical devices from three categories of Class III devices were assessed, namely, coronary stents, hip implants and silver-containing wound dressings. In more than 90% of the files, major shortcomings were found in one or more items in the documentation. This was particularly evident for the risk analysis and the clinical evaluation of the device. In addition, in many cases the coherence between identified residual risks in the risk analysis and warnings and precautions reported in the manufacturer's instructions for use of the device was insufficient. A manufacturer ought to provide an adequate description of the device, minimize the risks associated with using the device and substantiate the safety and performance of the device through adequate testing. The manufacturer should also provide detailed user instructions that include explicit information on the risks related to the use of the medical device.